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Clive Bates
Counterfactual 1
Nairobi
1 December 2022
Science behind Tobacco Harm Reduction and how
it impacts policy development and regulation
The Harm Reduction Exchange
2022
2
I am a former director of Action on Smoking and Health (UK)
I have supported tobacco harm reduction since 1997
I have no competing interests with respect to the tobacco, e-
cigarette, or pharmaceutical industries
Regulation for tobacco harm reduction
1. The problem is smoking
3
Well researched toll of harm from smoking
Smoking prematurely
kills around 8 million
annually
more than obesity,
alcohol, road accidents,
drug misuse and HIV
combined
4
Public Health England, Health Matters
similar to COVID-19,
but every year
Smoking prevalence in Africa  WHO (2021)
5
Published November 2021 South Africa
Nigeria
Ethiopia
Smoking prevalence in Africa  WHO (2021)
6
Published November 2021
South Africa
Ethiopia
Nigeria
Declining prevalence but increasing population will increase African share
7
Africa
Regulation for tobacco harm reduction
1. The problem is smoking
2. Smoke-free alternatives
8
People smoke for
the nicotine but
die from the tar
(1976)
Professor Michael Russell 1932-2009
The central insight in smoking and health
9
Russell MJ. Low-tar medium nicotine cigarettes: a new approach to safer smoking. BMJ 1976;1:14303
Smokeless tobacco
Tobacco based
Pure nicotine based
Heated
aerosol
Unheated
Vaping products Heated tobacco products
Heat-not-burn
Items are not shown to scale
Oral nicotine products
10
Royal College of Physicians  on relative risk
"Although it is not possible to
precisely quantify the long-
term health risks associated
with e-cigarettes, the
available data suggest that
they are unlikely to exceed
5% of those associated with
smoked tobacco products,
and may well be substantially
lower than this figure".
11
Royal College of Physicians. Nicotine without smoke: tobacco harm reduction London: RCP; 2016.
Department of Health (England)  on relative risk September 2022
12
McNeill et al. Nicotine Vaping in England, 2022
vaping poses only a
small fraction of the risks
of smoking
Much
lower
Much
lower
Much
lower
Much
lower
Much
lower
Much
lower
The strongest evidence for reduced harm is reduced exposure
13
Shahab L, Goniewicz ML, Blount BC, et al. Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and
Nicotine Replacement Therapy Users. Ann Intern Med 2017
Evidence from randomised controlled trials
14
There is highcertainty
evidence that e-
cigarettes with nicotine
increase quit rates
compared to NRT
Evidence for beneficial population effect triangulates
 Also, user testimony
 And it is what you would expect!!
15
Professor Robert West, UCL. Presentation at SRNT-Europe 2019
Regulation for tobacco harm reduction
1. The problem is smoking
2. Smoke-free alternatives
3. Policy and unintended consequences
16
The public health mechanism
17
Royal College of Physicians  perverse unintended consequences
18
Royal College of Physicians. Nicotine without smoke: tobacco harm reduction London: RCP; 2016.
if a risk-averse, precautionary approach
makes e-cigarettes:
 less easily accessible
 less palatable or acceptable
 more expensive
 less consumer friendly
 pharmacologically less effective
 inhibits innovation 
then it causes harm by perpetuating
smoking.
Royal College of Physicians  perverse unintended consequences
19
Royal College of Physicians. Nicotine without smoke: tobacco harm reduction London: RCP; 2016.
1. Prohibition of vaping and other smokefree products
1. Prohibition of vaping and other smokefree products
Dr Harsh Vardhan received the
award for spearheading the
Government of Indias legislation
to ban e-cigarettes and heated
tobacco products in 2019.
1. Prohibition of vaping and other smokefree products
22
Today, the country is faced with a
greater challenge, that of illegal
traffic in tobacco and its products.
So long as the demand within the
country persists, it will continue to
fuel the illicit market that has
expanded since the ban of its sale in
early 2000.
Unfortunately, as studies indicate,
Bhutanese youth are at the centre
of this growing illegal trade in
tobacco and its products.
WHO Office Bhutan: The Big Ban: Bhutans journey towards a tobacco-free society, 2019
2. Banning e-liquid flavours
23
2. Banning e-liquid flavours
Tobacco
Fruit
Dessert
or pastry
Choc,
sweets
Russell et al. vaping
flavour preferences
Russell C, et al. Changing patterns of first e-cigarette flavor used and current flavors used by
20,836 adult frequent e-cigarette users in the USA. Harm Reduct J. BioMed Central; 2018 24
2. Banning e-liquid flavours
25
 The intended outcome: abstinence from nicotine, vaping, smoking and any other vice
 Using tobacco flavoured vape products instead of other flavoured products
 Accessing flavoured vapes via an illicit supply chain (a black market)
 Relapsing back from vaping to smoking  both teenagers and adults
 Not switching from smoking to vaping and continuing to smoke
 Continuing to smoke or to start smoking as an adolescent because parents or adult role models smoke instead of vaping
 Using other tobacco or nicotine products  hand-rolling tobacco, smokeless tobacco, heated tobacco, or new nicotine pouches
 Buying from foreign suppliers in person or via the internet and importing for personal use
 Buying from foreign suppliers to resell to others through informal networks
 Making and mixing their own flavours at home or buying or selling home-mixed flavours
 Using vapes that are made to look tobacco flavoured but have other flavours
 Using flavour agents for food, drink or aromatherapy for adding to unflavoured nicotine liquids
 Using flavours made for vaping but ostensibly marketed for another purpose
 Switching to cannabinoid (THC or CBD) vapes
 Initiating smoking instead of initiating vaping
 Adopting another risk behaviour that may be worse
Friedman AS. A Difference-in-Differences Analysis of Youth Smoking and a Ban on Sales of Flavored Tobacco Products in San
Francisco, California. JAMA Pediatrics. 2021
2. Banning e-liquid flavours
Teenage smoking
increased following an
e-cigarette flavours ban
in San Francisco
Past-30-Day Smoking Trends Among High School Students Younger Than 18
Years
3. Banning advertising of vapes
27
3. Banning advertising of vapes
28
3. Banning advertising of vapes
29
 Dont be socially irresponsible
 Dont target or feature children
 Dont confuse e-cigarettes with tobacco products
 Dont make health or safety claims
 Dont make smoking cessation claims
 Dont mislead about product ingredients
 Dont mislead about where products may be use
Set standards avoid bans
4. Fear-based warnings
This product contains
nicotine which is a highly
addictive substance.
30
Required by EU Tobacco Products Directive 40/14/EU
4. Fear-based warnings
[Our findings] suggest that the
TPD nicotine addiction e-cigarette
health warning may reduce
smokers' willingness to use, and
likelihood of purchasing an e-
cigarette.
31
Cox S, et al Messages matter: The Tobacco Products Directive nicotine addiction health warning versus an alternative
relative risk message on smokers willingness to use and purchase an electronic cigarette. Addict Behav Reports, 2018
This product is likely to
be at least 95% safer
than smoking cigarettes
No product is completely
safe, but use of this
product is much less
harmful than smoking
4. Fear-based warnings
32
5. Taxing safer products
5. Taxing safer products
 Reduce teen e-cigarette use by 2.7 percentage
points, but that 2 in 3 teens who do not use e-
cigarettes due to the tax would smoke
cigarettes instead.
 .approximately a half million extra teenage
smokers overall.
  raise the number of daily adult cigarette
smokers by 2.5 million nationally and reduce
adult e-cigarette users by a similar number.
 For every e-cigarette pod eliminated by an e-
cigarette tax, more than 5.5 extra packs of
cigarettes are sold instead
Congress: raise e-cigarette taxes to a level
comparable to cigarette taxes
5. Taxing safer products
The solution: Risk-Proportionate Regulation
Measure Cigarettes, hand-rolling tobacco and other
combustibles
Taxation Relatively high taxes
Advertising Prohibit other than within trade
Warnings Graphic warnings depicting disease
Public places Legally mandated controls
Plain packaging Yes
Ingredients Control reward-enhancing additives
Age restrictions No sales to under-21s
Internet sales Banned
Product standards Control risks and reduce appeal
36
The solution: Risk-Proportionate Regulation
Measure Cigarettes, hand-rolling tobacco and other
combustibles
Vaping, heated tobacco smokeless and oral
nicotine
Taxation Relatively high taxes Low or zero tax (sales tax only)
Advertising Prohibit other than within trade Control themes and placement
Warnings Graphic warnings depicting disease Messages encouraging switching
Public places Legally mandated controls Up to the discretion of the owner
Plain packaging Yes No
Ingredients Control reward-enhancing additives Blacklist material health hazards
Age restrictions No sales to under-21s No sales to under-18s
Internet sales Banned Permitted with age controls
Product standards Control risks and reduce appeal Control risks
37
Regulations for tobacco harm reduction
1. The problem is smoking
2. Smoke-free alternatives
3. Policy and unintended consequences
4. Innovation (and its enemies)
38
A technology transition - cars
A technology transition - electricity
Innovation and its enemies
Claims about the promise of new technology are at times greeted with
skepticism, vilification or outright oppositionoften dominated by slander,
innuendo, scare tactics, conspiracy theories and misinformation.
The assumption that new technologies carry unknown risks guides much of
the debate. This is often amplified to levels that overshadow the dangers of
known risks.
Juma C. Innovation and Its Enemies: Why People Resist New Technologies. Oxford, New York: Oxford University Press; 2016.
Thankyou!
Counterfactual
clivedbates@gmail.com
www.clivebates.com
@clive_bates
1. The problem is smoking
2. Smoke-free alternatives
3. Policy and unintended consequences
4. Innovation (and its enemies)
Regulation for tobacco harm reduction

More Related Content

African Harm Reduction Exchange - Dec 2022

  • 1. Clive Bates Counterfactual 1 Nairobi 1 December 2022 Science behind Tobacco Harm Reduction and how it impacts policy development and regulation The Harm Reduction Exchange 2022
  • 2. 2 I am a former director of Action on Smoking and Health (UK) I have supported tobacco harm reduction since 1997 I have no competing interests with respect to the tobacco, e- cigarette, or pharmaceutical industries
  • 3. Regulation for tobacco harm reduction 1. The problem is smoking 3
  • 4. Well researched toll of harm from smoking Smoking prematurely kills around 8 million annually more than obesity, alcohol, road accidents, drug misuse and HIV combined 4 Public Health England, Health Matters similar to COVID-19, but every year
  • 5. Smoking prevalence in Africa WHO (2021) 5 Published November 2021 South Africa Nigeria Ethiopia
  • 6. Smoking prevalence in Africa WHO (2021) 6 Published November 2021 South Africa Ethiopia Nigeria
  • 7. Declining prevalence but increasing population will increase African share 7 Africa
  • 8. Regulation for tobacco harm reduction 1. The problem is smoking 2. Smoke-free alternatives 8
  • 9. People smoke for the nicotine but die from the tar (1976) Professor Michael Russell 1932-2009 The central insight in smoking and health 9 Russell MJ. Low-tar medium nicotine cigarettes: a new approach to safer smoking. BMJ 1976;1:14303
  • 10. Smokeless tobacco Tobacco based Pure nicotine based Heated aerosol Unheated Vaping products Heated tobacco products Heat-not-burn Items are not shown to scale Oral nicotine products 10
  • 11. Royal College of Physicians on relative risk "Although it is not possible to precisely quantify the long- term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure". 11 Royal College of Physicians. Nicotine without smoke: tobacco harm reduction London: RCP; 2016.
  • 12. Department of Health (England) on relative risk September 2022 12 McNeill et al. Nicotine Vaping in England, 2022 vaping poses only a small fraction of the risks of smoking
  • 13. Much lower Much lower Much lower Much lower Much lower Much lower The strongest evidence for reduced harm is reduced exposure 13 Shahab L, Goniewicz ML, Blount BC, et al. Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users. Ann Intern Med 2017
  • 14. Evidence from randomised controlled trials 14 There is highcertainty evidence that e- cigarettes with nicotine increase quit rates compared to NRT
  • 15. Evidence for beneficial population effect triangulates Also, user testimony And it is what you would expect!! 15 Professor Robert West, UCL. Presentation at SRNT-Europe 2019
  • 16. Regulation for tobacco harm reduction 1. The problem is smoking 2. Smoke-free alternatives 3. Policy and unintended consequences 16
  • 17. The public health mechanism 17
  • 18. Royal College of Physicians perverse unintended consequences 18 Royal College of Physicians. Nicotine without smoke: tobacco harm reduction London: RCP; 2016.
  • 19. if a risk-averse, precautionary approach makes e-cigarettes: less easily accessible less palatable or acceptable more expensive less consumer friendly pharmacologically less effective inhibits innovation then it causes harm by perpetuating smoking. Royal College of Physicians perverse unintended consequences 19 Royal College of Physicians. Nicotine without smoke: tobacco harm reduction London: RCP; 2016.
  • 20. 1. Prohibition of vaping and other smokefree products
  • 21. 1. Prohibition of vaping and other smokefree products Dr Harsh Vardhan received the award for spearheading the Government of Indias legislation to ban e-cigarettes and heated tobacco products in 2019.
  • 22. 1. Prohibition of vaping and other smokefree products 22 Today, the country is faced with a greater challenge, that of illegal traffic in tobacco and its products. So long as the demand within the country persists, it will continue to fuel the illicit market that has expanded since the ban of its sale in early 2000. Unfortunately, as studies indicate, Bhutanese youth are at the centre of this growing illegal trade in tobacco and its products. WHO Office Bhutan: The Big Ban: Bhutans journey towards a tobacco-free society, 2019
  • 23. 2. Banning e-liquid flavours 23
  • 24. 2. Banning e-liquid flavours Tobacco Fruit Dessert or pastry Choc, sweets Russell et al. vaping flavour preferences Russell C, et al. Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA. Harm Reduct J. BioMed Central; 2018 24
  • 25. 2. Banning e-liquid flavours 25 The intended outcome: abstinence from nicotine, vaping, smoking and any other vice Using tobacco flavoured vape products instead of other flavoured products Accessing flavoured vapes via an illicit supply chain (a black market) Relapsing back from vaping to smoking both teenagers and adults Not switching from smoking to vaping and continuing to smoke Continuing to smoke or to start smoking as an adolescent because parents or adult role models smoke instead of vaping Using other tobacco or nicotine products hand-rolling tobacco, smokeless tobacco, heated tobacco, or new nicotine pouches Buying from foreign suppliers in person or via the internet and importing for personal use Buying from foreign suppliers to resell to others through informal networks Making and mixing their own flavours at home or buying or selling home-mixed flavours Using vapes that are made to look tobacco flavoured but have other flavours Using flavour agents for food, drink or aromatherapy for adding to unflavoured nicotine liquids Using flavours made for vaping but ostensibly marketed for another purpose Switching to cannabinoid (THC or CBD) vapes Initiating smoking instead of initiating vaping Adopting another risk behaviour that may be worse
  • 26. Friedman AS. A Difference-in-Differences Analysis of Youth Smoking and a Ban on Sales of Flavored Tobacco Products in San Francisco, California. JAMA Pediatrics. 2021 2. Banning e-liquid flavours Teenage smoking increased following an e-cigarette flavours ban in San Francisco Past-30-Day Smoking Trends Among High School Students Younger Than 18 Years
  • 27. 3. Banning advertising of vapes 27
  • 28. 3. Banning advertising of vapes 28
  • 29. 3. Banning advertising of vapes 29 Dont be socially irresponsible Dont target or feature children Dont confuse e-cigarettes with tobacco products Dont make health or safety claims Dont make smoking cessation claims Dont mislead about product ingredients Dont mislead about where products may be use Set standards avoid bans
  • 30. 4. Fear-based warnings This product contains nicotine which is a highly addictive substance. 30 Required by EU Tobacco Products Directive 40/14/EU
  • 31. 4. Fear-based warnings [Our findings] suggest that the TPD nicotine addiction e-cigarette health warning may reduce smokers' willingness to use, and likelihood of purchasing an e- cigarette. 31 Cox S, et al Messages matter: The Tobacco Products Directive nicotine addiction health warning versus an alternative relative risk message on smokers willingness to use and purchase an electronic cigarette. Addict Behav Reports, 2018
  • 32. This product is likely to be at least 95% safer than smoking cigarettes No product is completely safe, but use of this product is much less harmful than smoking 4. Fear-based warnings 32
  • 33. 5. Taxing safer products
  • 34. 5. Taxing safer products Reduce teen e-cigarette use by 2.7 percentage points, but that 2 in 3 teens who do not use e- cigarettes due to the tax would smoke cigarettes instead. .approximately a half million extra teenage smokers overall. raise the number of daily adult cigarette smokers by 2.5 million nationally and reduce adult e-cigarette users by a similar number. For every e-cigarette pod eliminated by an e- cigarette tax, more than 5.5 extra packs of cigarettes are sold instead Congress: raise e-cigarette taxes to a level comparable to cigarette taxes
  • 35. 5. Taxing safer products
  • 36. The solution: Risk-Proportionate Regulation Measure Cigarettes, hand-rolling tobacco and other combustibles Taxation Relatively high taxes Advertising Prohibit other than within trade Warnings Graphic warnings depicting disease Public places Legally mandated controls Plain packaging Yes Ingredients Control reward-enhancing additives Age restrictions No sales to under-21s Internet sales Banned Product standards Control risks and reduce appeal 36
  • 37. The solution: Risk-Proportionate Regulation Measure Cigarettes, hand-rolling tobacco and other combustibles Vaping, heated tobacco smokeless and oral nicotine Taxation Relatively high taxes Low or zero tax (sales tax only) Advertising Prohibit other than within trade Control themes and placement Warnings Graphic warnings depicting disease Messages encouraging switching Public places Legally mandated controls Up to the discretion of the owner Plain packaging Yes No Ingredients Control reward-enhancing additives Blacklist material health hazards Age restrictions No sales to under-21s No sales to under-18s Internet sales Banned Permitted with age controls Product standards Control risks and reduce appeal Control risks 37
  • 38. Regulations for tobacco harm reduction 1. The problem is smoking 2. Smoke-free alternatives 3. Policy and unintended consequences 4. Innovation (and its enemies) 38
  • 40. A technology transition - electricity
  • 41. Innovation and its enemies Claims about the promise of new technology are at times greeted with skepticism, vilification or outright oppositionoften dominated by slander, innuendo, scare tactics, conspiracy theories and misinformation. The assumption that new technologies carry unknown risks guides much of the debate. This is often amplified to levels that overshadow the dangers of known risks. Juma C. Innovation and Its Enemies: Why People Resist New Technologies. Oxford, New York: Oxford University Press; 2016.
  • 42. Thankyou! Counterfactual clivedbates@gmail.com www.clivebates.com @clive_bates 1. The problem is smoking 2. Smoke-free alternatives 3. Policy and unintended consequences 4. Innovation (and its enemies) Regulation for tobacco harm reduction

Editor's Notes

  1. Vaping products Top row shows: 1st generation cig-a-likes 2nd generation ego or pen type devices 3rd generation tanks / mods type Bottom row shows Large electronic hookah Small shisha pipes Electronic pipe there are many other configurations Heated tobacco products sometimes referred to as heat-not-burn to distinguish between combustible products Shows the iQOs, Ploom and Glo products Novel nicotine products - shows Nicoccino a nicotine containing film Zonnic a range of nicotine products lozenges, gum etc Voke a cold aerosol (approved but not marketed) Niorette cross-over NRT Smokeless tobacco Snus Moist snuff Tobacco-based lozenge